Comparison Between C3-6 Laminoplasty and C3 Laminectomy With Cervical Laminoplasty

Seoul National University

Status: Completed

Conditions: Kyphosis Post Surgical; Cervical Spondylosis With Myelopathy; Ossification of Posterior Longitudinal Ligament; Myelopathy Cervical; Neck Pain

Treatments: Procedure: C3 laminoplasty; Procedure: C3 laminectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05006495

1610-136-804

Details and patient eligibility

About

Investigators performed a prospective randomized controlled trial for comparing postoperative clinical and radiological outcomes between C3 laminectomy with laminoplasty and C3-6 laminoplasty.

Full description

Cervical laminoplasty is widely performed surgical techniques to cervical myelopathy patients. But it is well known that C3-6 Cervical laminoplasty often results in injury of the semispinalis cervicis inserted into the axis, which possibly causes postoperative cervical kyphosis and neck pain. C3 laminectomy with cervical laminoplasty is the modified technique preserving the semispinalis cervicis to reduce such complications of conventional C3-6 laminoplasty.

There has been a number of retrospective studies comparing C3 laminectomy with laminoplasty and C3-6 laminoplasty, however, there's no prospective randomized controlled study yet. Investigators performed a prospective randomized controlled trial for comparing postoperative clinical and radiological outcomes between C3 laminectomy with laminoplasty and C3-6 laminoplasty. Primary end points include the C2-7 spine cobb anlge, Neck Disability Index(NDI) at postoperative 1~3 year

Enrollment: 126 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cervical stenosis patients with or without cervical myelopathy.

Exclusion criteria

• Metastatic cancer patients.
• Any combined fracture.
• Previous surgery to cervical spine.
• inflammatory joint disease
• psychiatric illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 2 patient groups

C3 laminectomy with C4-6 laminoplasty

Experimental group

Description:

Cervical myelopathy patients who underwent C3 laminectomy with laminoplasty.

Treatment:

Procedure: C3 laminectomy

C3-6 laminoplasty

Active Comparator group

Description:

Cervical myelopathy patients who underwent C3-6 laminoplasty.

Treatment:

Procedure: C3 laminoplasty